ST elevation myocardial infarction MedDRA version: 17.1 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Metalyse
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: TENECTEPLASE
CAS Number: 191588-94-0
Concentration unit: U unit(s)
Concentration type: up
Sponsors
Consorci MAr Parc de Salut de Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Chest pain suggestive of myocardial ischemia for at least 30 minutes -Symptoms onset less than 12 hours before hospital admission -ST segment elevation of at least 1 mm in two or more contiguous leads (>o = 2mm in precordial leads) -To understand and accept the study procedures and signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: -ST elevation myocardial infarction presenting with cardiogenic shock -Previous myocardial infarction (< 6 months) -Formal contraindication to thrombolysis or to prasugrel -Patients on oral anticoagulation therapy -Patients treated with vitamin K, bivalirudin or fondaparinux -Patients with severe renal failure (glomerular filtration rate <30ml/min/m2) -Patients with contraindication to study medications, which cannot be managed medically, including: adenosine, heparin, IIb-IIIa inhibitors, contrast agents, clopidogrel, ticagrelor, prasugrel or aspirin -Known life-threatening disease with a life expectancy of <12 months -Inability to obtain informed consent -Patients with contraindications to cardiovascular magnetic resonance -Pregnant or breastfeeding patient -Allergic reaction to the product (Methylase) and/or excipient -Patients presenting with pace rhytm, preexcitation or other conditions or artifacts interfering with the interpretation of ST segment resolution -Patient presenting with second or third degree of atrioventricular block or need of temporal pacemarker -Culprit lesion located in small segments or secundary branches <2.5 mm diameter -Impossibility to advance thrombectomy/Amicath device due to extreme tortuosy or calcification -Significant left main disease -Thrombolysis in myocardial infarction (TIMI) flow 3 without the visualization of intracoronary thrombus at initial angiography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Safety;Primary end point(s): Necrotic myocardial volume (in mL/m2 and in % of LV mass) by contrast enhanced cardiovascular magnetic resonance;Timepoint(s) of evaluation of this end point: Outcome measured during the first 7 days after the ST elevation myocardial infarction;Main Objective: The main objective is to investigate whether pharmacological treatment guided by the angiographic evidence of thrombus(intracoronary thrombolysis) in percutaneous coronary intervention is more effective than standard percutaneous coronary intervention (manual thrombectomy) in achieving an optimal epicardial and myocardial reperfusion to minimize the size of myocardial necrosis in the setting of acute ST elevation myocardial infarction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Timepoints of evaluation of endpoints: 1-6, 12. after the procedure 7. during admission 8-10. during admission and at 30 days, 6 months and 12 months 11. during follow up (12 months);Secondary end point(s): 1.Microvascular obstruction as a dichotomic variable and as myocardial volume (in mL/m2 and as a % of left ventricle mass) 2.Salvage myocardium volume (as % of left ventricle mass) 3.Segmental transmurality (at least >50% of the transmural depth and at least 50% of the extension of the segment) 4.Rate of ST-segment resolution at 60 minutes after the completion of primary PCI 5.Post-procedural: TIMI flow grade (TFG) 6.Post-procedural TIMI BLUSH myocardial grade (TBG) and TIMI trombus grade (TTG) 7.TIMI bleeding events 8.Cardiac death 9.Combination of cardiac death and non-fatal re-infarction 10.Major cardiac events (MACE) 11.Stent thrombosis according to the ARC definitions 12. Measurament of residual thrombus by optical coherence tomography | — |
Countries
Spain
Contacts
Public ContactServicio de Cardiologia
Cardiologia intervencionista e Imagen Cardiaca (CMR). Servicio de Cardiologia
Outcome results
None listed